January 27, 2022

INTRIGUE Phase III study of Qinlock fails to meet primary endpoint in gastrointestinal stromal tumor – Deciphera Pharmaceuticals

Deciphera Pharmaceuticals announced top-line results from the INTRIGUE Phase III clinical study of Qinlock (ripretinib) in patients with gastrointestinal stromal tumor (GIST) previously treated with imatinib. The study did not meet the primary endpoint of improved progression-free survival (PFS) compared with the standard of care. In the study, 453 patients were randomized 1:1 to either Qinlock 150 mg once daily […]

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January 26, 2022

FDA grants Tentative Approval for Yutrepia to treat pulmonary arterial hypertension – Liquidia Corpn

Liquidia Corporation has announced that the FDA granted tentative approval for Yutrepia (treprostinil) inhalation powder, previously referred to as LIQ 861. Yutrepia is indicated for the treatment of pulmonary arterial hypertension (PAH) to improve exercise ability in adult patients with New York Heart Association (NYHA) Functional Class II-III symptoms. Tentative approval indicates that Yutrepia has met all regulatory standards for […]

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January 25, 2022

Phase III FURI study of ibrexafungerp shows positive clinical results in multiple fungal infections – Scynexis

Scynexis announced an oral presentation of analyses of interim data from its ongoing Phase III FURI study showing favorable clinical activity of oral Brexafemme (ibrexafungerp) in severe hospital-based fungal infections across multiple serious fungal infections. Data from an interim analysis of the combined data of 74 patients from the Phase III FURI clinical study evaluating oral ibrexafungerp for the treatment […]

admin Health 0 1 min read
January 24, 2022

New comprehensive phase III data show first-in-class Tremfya provided durable improvements in measures of psoriatic arthritis through two years – Johnson & Johnson

The Janssen Pharmaceutical Companies of Johnson & Johnson announced comprehensive efficacy and safety data from the DISCOVER–2 trial of Tremfya (guselkumab) were published in Arthritis & Rheumatology, representing the final results of the first two-year clinical trial investigating a selective interleukin (IL)-23 inhibitor therapy in active psoriatic arthritis (PsA). Results show a majority of Tremfya-treated biologic-naïve adult patients with active […]

admin Health 0 5 min read
January 23, 2022

Roche presents new data for Evrysdi at World Muscle Society (WMS) 2021 highlighting new advances for people living with rare neuromuscular disorders

Roche announced data from across its growing neuromuscular portfolio at the World Muscle Society (WMS) Virtual Congress 20 – 24 September 2021. The presentations included additional results from the RAINBOWFISH study, evaluating the efficacy and safety of Evrysdi (risdiplam) in babies with pre-symptomatic spinal muscular atrophy (SMA) from birth to six weeks of age and data. At WMS 2021, data […]

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January 22, 2022

FDA approves Keytruda plus chemotherapy for cervical cancer – Merck

Merck Inc., announced that the FDA has approved Keytruda (pembrolizumab) in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (Combined Positive Score [CPS] at least 1) as determined by an FDA-approved test. The approval is based on the Phase III KEYNOTE-826 trial evaluating Keytruda plus […]

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January 18, 2022

MHRA approves Bylvay for progressive familial intrahepatic cholestasis – Albireo Pharma

Albireo Pharma announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorization for Bylvay (odevixibat) for the treatment of all types of progressive familial intrahepatic cholestasis (PFIC). The MHRA authorization follows the European Commission (EC) authorization of Bylvay in July 2021. The MHRA authorization was based on data from PEDFIC 1 and PEDFIC 2, the […]

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January 14, 2022

New real-world data show high rate of patient adherence to Tepezza for thyroid eye disease (TED) – Horizon Therapeutics

Horizon Therapeutics plc announced findings of a real-world adherence analysis of Tepezza for the treatment of TED ( Thyroid Eye Disease) at the American Academy of Ophthalmology Annual Meeting (AAO 2021). Tepezza is the first and only medicine approved by the FDA for the treatment of TED – a serious, progressive and potentially vision-threatening rare autoimmune disease. The analysis found […]

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January 8, 2022

FDA approves Dupixent as add-on treatment for moderate-to-severe asthma – Sanofi + Regeneron

The FDA has approved Dupixent (dupilumab), from Sanofi + Regeneron, as an add-on maintenance treatment of patients aged 6 to 11 years with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma. The FDA approval is based on data from a Phase III randomized, double-blind, placebo-controlled trial that evaluated the efficacy and safety of Dupixent combined with […]

admin Health 0 1 min read
January 7, 2022

FDA application for first dispersible single tablet regimen containing dolutegravir (DTG) for children living with HIV – ViiV HealthCare

ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, has announced it has made a regulatory submission to the FDA for approval of a new dispersible tablet formulation of the fixed dose combination of abacavir, dolutegravir and lamivudine and, to extend its current approval for Triumeq (abacavir/ dolutegravir/ lamivudine) to lower […]

admin Health 0 48 sec read

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